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NCT03594630
Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
EARLY_PHASE1 trial testing Chemotherapy in Rectal Adenocarcinoma in 120 participants. Currently enrolling.
31 October 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 13 March 2024 |
| Primary completion | 31 October 2026 |
| Estimated completion | 31 October 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Chemotherapy (chemotherapy) — full drug profile →
- Patient Observation
- Questionnaire Administration
- Resection of Rectum
Conditions studied
- Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →
- Stage II Rectal Cancer AJCC v8 — all drugs for Stage II Rectal Cancer AJCC v8 →
- Stage IIA Rectal Cancer AJCC v8 — all drugs for Stage IIA Rectal Cancer AJCC v8 →
- Stage IIB Rectal Cancer AJCC v8 — all drugs for Stage IIB Rectal Cancer AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Rectal Adenocarcinoma or Stage II Rectal Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03594630
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03594630 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 6 November 2025
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/NCT03594630.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing