Last reviewed · How we verify
NCT01211938: JANORL2
Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract
Phase 2, PHASE3 trial testing single-fraction radiotherapy with concomitant 5FU and Hydrea in Squamous Cell Carcinoma in 60 participants. Completed in 25 February 2017.
25 February 2017
Quick facts
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 June 2010 |
| Primary completion | 25 February 2017 |
| Estimated completion | 25 February 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- single-fraction radiotherapy with concomitant 5FU and Hydrea
- hyperfractionated radiotherapy with concomitant Cetuximab
Conditions studied
- Squamous Cell Carcinoma — all drugs for Squamous Cell Carcinoma →
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris — full company profile →
Who can join
Adults 18 to 70, any sex, with Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of \< 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01211938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT07095608 — Defining TRPV4 Contribution of Schwann Cells to Oral Cancer Pain · NA · recruiting
- NCT06996249 — Prospective Data Collection Initiative on Thoracic Malignancies · recruiting
Other Gustave Roussy, Cancer Campus, Grand Paris trials
Trials by the same sponsor.
- NCT07303387 — Efficacy and Safety of the Valemetostat in Patients With Selected Solid Tumors. · Phase 2 · not yet recruiting
- NCT07159451 — A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovaria · Phase 2 · recruiting
- NCT06781996 — A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuva · Phase 3 · recruiting
- NCT07016230 — Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and · Phase 2 · recruiting
- NCT06902883 — Study on the Effectiveness and Comfort of Innovative Solutions for the Internal Transport of Patients in Wheelchairs in · Phase 2 · completed
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 NCT01211938 (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 Gustave Roussy, Cancer Campus, Grand Paris
- Last refreshed: 16 May 2017
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/NCT01211938.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing