Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck Cancer

NCT01716195 | Completed Phase 2 Results DMC

• 2 other identifiers: 359512CCRO022
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether human papillomavirus (HPV)-positive head and neck cancer can be treated with a less aggressive regimen of radiation therapy and chemotherapy (paclitaxel) after initially receiving two cycles of chemotherapy (carboplatin/paclitaxel).

Conditions

Head and Neck Cancer

Keywords

Human Papillomavirus; HPV

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression-free Survival

  Defined from date of registration to date of first documentation of progression and/or distant metastasis, or death due to any cause. The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.

  Up to 2 years

Secondary Outcomes (2)

• Number of Participants With Overall Survival

  Up to 5 years

• Number of Patients With Toxicity of Concurrent Chemoradiotherapy

  Up to 5 years

Study Arms (1)

Response Adapted Chemoradiation

EXPERIMENTAL

Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel

Radiation: Induction Chemotherapy followed by Response Adapted Chemoradiation

Interventions

Induction Chemotherapy followed by Response Adapted Chemoradiation RADIATION

All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.

Also known as: Paclitaxel, Carboplatin

Response Adapted Chemoradiation

Eligibility Criteria

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

You may qualify if:

• Pathologically proven diagnosis of HPV-positive squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry.
• Clinical stage III or IV disease; Note: Patients with M1 tumors are not eligible.
• Appropriate stage for protocol entry, including no distant metastases, based upon minimum diagnostic workup
• Zubrod Performance Status 0-1
• Age \> 18
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function
• Pregnancy test within 4 weeks prior to registration for women of childbearing potential
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment)
• Patient must sign study specific informed consent prior to study entry.

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
• Patients with simultaneous primaries or bilateral tumors are excluded.
• Patients who present with a cervical lymph node metastasis of unknown primary origin;
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
• Prior radiotherapy that would result in overlap of radiation therapy fields;
• Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses, or salivary glands;
• Recurrent head and neck cancer;
• Severe, active co-morbidity
• Prior allergic reaction to the study drug(s) involved in this protocol.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Chen AM, Felix C, Wang PC, Hsu S, Basehart V, Garst J, Beron P, Wong D, Rosove MH, Rao S, Melanson H, Kim E, Palmer D, Qi L, Kelly K, Steinberg ML, Kupelian PA, Daly ME. Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):803-811. doi: 10.1016/S1470-2045(17)30246-2. Epub 2017 Apr 20.

  PMID: 28434660 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Dr. Megan Daly
• Organization: University of California Davis

medaly@ucdavis.edu

916-734-5428

Study Officials

• Megan Daly, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: March 8, 2017
• Study Completion: October 1, 2020
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-02

Locations

US (1)