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Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
Phase 2 trial testing Cisplatin in Anal Canal Squamous Cell Carcinoma in 8 participants. Completed in 3 June 2022.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 8 November 2018 |
| Primary completion | 3 June 2022 |
| Estimated completion | 3 June 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
Adults 18 to 85, any sex, with Anal Canal Squamous Cell Carcinoma or Stage I Anal Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 2 |
Number (percentage) patients who achieved a complete clinical response of their disease by 12 weeks after chemoradiation.
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 6 |
Patients alive without evidence of local progression 24 months after chemoradiation.
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 5 |
Patients alive without evidence of distant metastases 24 months after chemoradiation.
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 5 |
Patients alive 24 months after chemoradiation.
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 7 |
Number (percentage) patients who achieved a complete clinical response of their disease by 24 weeks after chemoradiation.
| Group | Value | 95% CI |
|---|---|---|
| IMPT for Anal Cancer (Single Arm Trial) | 6 |
Time frame: Assessed up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | IMPT for Anal Cancer (Sing… |
|---|---|---|
| Absolute lymphocyte decrease | Blood and lymphatic system disorders | — |
| Absolute lymphocyte decrease | Blood and lymphatic system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — |
| Absolute lymphocyte decrease | Blood and lymphatic system disorders | — |
| Creatinine increased | Renal and urinary disorders | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Absolute monocyte decrease | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| White blood cell count decreased | Blood and lymphatic system disorders | — |
| Absolute eosinophil decrease | Blood and lymphatic system disorders | — |
| Anal bleeding | Gastrointestinal disorders | — |
| Anorectal pain | Gastrointestinal disorders | — |
| BUN increase | Renal and urinary disorders | — |
| Chloride level decrease | Metabolism and nutrition disorders | — |
| Total protein decreased | Metabolism and nutrition disorders | — |
| Absolute neutrophil decrease | Blood and lymphatic system disorders | — |
| Absolute neutrophil increase | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Hypercalcemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| PICC line pain | General disorders | — |
| Platelet count decreased | Blood and lymphatic system disorders | — |
| Abnormal bowel habits | Gastrointestinal disorders | — |
| Absolute lymphocyte decrease | Blood and lymphatic system disorders | — |
| Absolute neutrophil increase | Blood and lymphatic system disorders | — |
| Acute kidney disease | Renal and urinary disorders | — |
| Alkaline phosphatase increase | Blood and lymphatic system disorders | — |
| Alkaline phosphatase increase | Blood and lymphatic system disorders | — |
| Anal fissure | Gastrointestinal disorders | — |
| Anorectal pain | Gastrointestinal disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| AST Increased | Blood and lymphatic system disorders | — |
| Back pain | Gastrointestinal disorders | — |
Data from ClinicalTrials.gov NCT03690921 adverse events section.
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03690921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing