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Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
Phase 3 trial testing Brachytherapy in Cervical Adenocarcinoma in 926 participants. Completed in 9 July 2021.
| Lead sponsor | GOG Foundation |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 926 |
| Start date | 9 January 2012 |
| Primary completion | 9 July 2021 |
| Estimated completion | 9 July 2021 |
| Sites | 326 locations across Saudi Arabia, Canada, China, Singapore, United States |
GOG Foundation
18 and older, female only, with Cervical Adenocarcinoma or Cervical Adenosquamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Estimate for probability of overall survival at 5 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 71 | 66 – 75 |
| Standard Chemoradiation With Adjuvant Chemotherapy | 72 | 67 – 76 |
Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study.
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 62 | 57 – 66 |
| Standard Chemoradiation With Adjuvant Chemotherapy | 63 | 58 – 68 |
Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 13 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 14 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 4 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 1 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 0 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 32 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 64 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 3 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 2 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 1 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 1 |
Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 15 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 33 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 47 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 51 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 42 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 53 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 37 |
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 304 | |
| Standard Chemoradiation With Adjuvant Chemotherapy | 332 |
Radiation protocol compliance measured by external beam dose delivered
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 45.6 | 1.8 – 85.0 |
| Arm B | 45.7 | 4.5 – 90.0 |
Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Standard Chemoradiation | 1.7 | ± 22.8 |
| Standard Chemoradiation With Adjuvant Chemotherapy | 2.4 | ± 26.3 |
Time frame: Through study completion with a median follow-up being 60 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Standard Chemoradiation | Standard Chemoradiation Wi… |
|---|---|---|---|
| General disorders NOS | General disorders | — | — |
| Reaction | System | Standard Chemoradiation | Standard Chemoradiation Wi… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Vaginal discharge | Reproductive system and breast disorders | — | — |
| Pelvic pain | Reproductive system and breast disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Cystitis noninfective | Renal and urinary disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Peripheral motor neuropathy | Nervous system disorders | — | — |
| Dermatitis radiation | Injury, poisoning and procedural complications | — | — |
| Creatinine increased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Hearing impaired | Ear and labyrinth disorders | — | — |
| Vaginal pain | Reproductive system and breast disorders | — | — |
| Hemorrhage Bladder | Renal and urinary disorders | — | — |
| Urinary tract pain | Renal and urinary disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Hemorrhage Rectum | Gastrointestinal disorders | — | — |
| Proctitis | Gastrointestinal disorders | — | — |
| Vaginal dryness | Reproductive system and breast disorders | — | — |
| Allergic reaction/ hypersensitivity | Immune system disorders | — | — |
| Vaginal stricture | Reproductive system and breast disorders | — | — |
| Thrombosis/Thrombus/Embolism | Hepatobiliary disorders | — | — |
| Rectal pain | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Lymphedema | Vascular disorders | — | — |
| Anal pain | Gastrointestinal disorders | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — |
| Female genital tract fistula | Reproductive system and breast disorders | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
Most-reported serious reactions: General disorders NOS.
Data from ClinicalTrials.gov NCT01414608 adverse events section.
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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