A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy

NCT03371550 | Completed Phase 2 DMC

• 1 other identifier: 2004/07
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. The aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and 22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5 fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate. Secondary objectives are toxicity, time to progression, and overall survival.

Conditions

Locally Advanced Non-small Cell Lung Cancer

Keywords

Concurrent 3-D chemoradiotherapy,Docetaxel,Cisplatin,Chemotherapy ·

Outcome Measures

Primary Outcomes (1)

• To evaluate the antitumor activity of Docetaxel - Cisplatin and concomitant thoracic radiotherapy after Docetaxel - Cisplatin induction chemotherapy in patients with locally advanced non-operable NSCLC by tumor response rate

  Tumor Response rate between 6 and 8 weeks according to RECIST 1.0 criteria after the end of radiotherapy (except in the case of early progression) that patients: * having received at least 4 weekly injections of Docetaxel and Cisplatin, * who have received the full radiotherapy treatment (except in case of cessation for toxicity, in which case the patients will be evaluable).

  up to 3 years

Secondary Outcomes (5)

• Overall survival and at 12 months

  up to 3 years

• Response delay

  up to 3 years

• Progression Free Survival

  up to 3 years

• Tolerance profile of the association in terms of immediate and delayed toxicity

  up to 3 years

• Quality of Life evaluation (EORTC QLQ-C30 and QLQ-LC13)

  up to 3 years

Study Arms (1)

Radiochemotherapy

EXPERIMENTAL

Induction chemotherapy with docetaxel and cisplatine and concomitant radiotherapy

Drug: Docetaxel; Radiation: concomitant radiotherapy; Drug: Cisplatin

Interventions

Docetaxel DRUG

Induction chemotherapy

Radiochemotherapy

concomitant radiotherapy RADIATION

Pulmonary and mediastinal radiotherapy

Radiochemotherapy

Cisplatin DRUG

Induction chemotherapy

Radiochemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically confirmed NSCLC,
• stage IIIB (excluding malignant pleural or pericardial effusions, tumoral volume exceeding one radiation field,
• N3 supraclavicular, and contralateral hilar nodal involvement) or inoperable stage IIIA defined by the new International Staging System \[21\],
• ≤ age ≤ 75 years,
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2,
• weight loss \<10%,
• at least one measurable lesion according to RECIST 1.0 criteria,
• adequate hematopoietic function (absolute neutrophil count ≥2 × 109/l, platelets ≥100 × 109/l, and hemoglobin level ≥10g/dl), adequate hepatic function \[total serum bilirubin less than or equal to the institutional upper limit of normal (ULN), aspartate aminotransferase ≤1.5× ULN, and alkaline phosphatase ≤5× ULN\], and adequate renal function (serum creatinine ≤1.5× ULN).

You may not qualify if:

• patients previously treated with radiotherapy or chemotherapy for NSCLC,
• previous cancer except basocellular carcinoma and in situ carcinoma of the cervix curatively treated and other cancers curatively treated for at least 5 years,
• peripheral neuropathy NCI-CTC grade ≥2,
• noncontroled severe disease,
• pregnant or breast-feeding women.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

MeSH Terms

Interventions

Docetaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a prospective, open-label, multicentric, phase II study.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 13, 2017
• Study Start: August 5, 2004
• Primary Completion: October 31, 2010
• Study Completion: October 31, 2011
• Last Updated: December 13, 2017

Record last verified: 2017-11